Ubiquinone vs. Ubiquinol Supplementation

Last updated: April 7, 2025
Sponsor: Trio Fertility
Overall Status: Active - Recruiting

Phase

2

Condition

In Vitro Fertilization

Treatment

Ubiquinol 100 MG Oral Capsule

Ubiquinone 200 Mg Oral Capsule

Clinical Study ID

NCT06555575
K001
  • Ages 37-43
  • Female
  • Accepts Healthy Volunteers

Study Summary

The objective of this study is to determine if ubiquinol will result in improved reproductive outcomes in older women at a reduced oral dose compared to current standard treatment with ubiquinone.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Women age >37 and <43 years undergoing their first in vitro fertilization (IVF)cycle

  2. Day 3 follicle-stimulating hormone (FSH) <12 IU/L with serum estradiol <250 pmol/Land normal thyroid-stimulating hormone (TSH) and Prolactin

  3. Partner with semen analysis suitable for IVF or ICSI

  4. Anti-müllerian hormone (AMH) > 3 pmol/L

  5. Be willing and able to provide written informed consent for the study.

  6. Be an otherwise healthy female and considered eligible by the investigator to betreated with a daily dose of 225 IU Recombinant human FSH (recFSH) and 75 IU Humanmenopausal gonadotrophins (hMG).

  7. Documented history of infertility for at least 12 months before randomization (notapplicable in case of tubal infertility or severe male factor infertility, or whenthe use of donor sperm is indicated)

  8. Have a body mass index (BMI) ≥17.5 and ≤38 kg/m2

  9. Have available ejaculatory sperm (use of donated and/or cryopreserved sperm isallowed)

  10. Have a normal uterine cavity (no evidence of uterine polyp or submucosal fibroid) asassessed by either saline-infused sonohysterography or by hysteroscopy within 12months of randomization

  11. Have results of clinical laboratory tests (hematology, serum chemistry, andurinalysis) within normal limits or clinically acceptable to the investigator

  12. Has a pelvic ultrasound showing no cyst ≥15 mm

Exclusion

Exclusion Criteria:

  1. Has been diagnosed with or treated for any endocrine abnormality within 3 yearsprior Note: Participants with a history of clinical or subclinical hypothyroidismmay be eligible if thyroid stimulating hormone levels at screening are within normallimits and the participant has been on a stable dose of thyroid replacementmedication (or on no replacement therapy) for at least 8 weeks.

  2. Has a prolactin level above the upper limit of normal for the central laboratory

  3. Has FSH >12.0 IU/L

  4. Has a history of a full or partial resection of an ovary, including a history ofovarian cystectomy, or of any ovarian tumors limiting access to the ovary duringovum pick-up, e.g., endometriomas or teratomas measuring >10 mm

  5. Has unilateral or bilateral hydrosalpinx that communicates with the endometrialcavity on screening ultrasound or hysterosalpingography.

  6. Has intramural fibroids ≥3 cm or submucosal fibroids of any size

  7. Has Asherman's syndrome (untreated) or endometrial polyps that have not beenresected

  8. Has any congenital uterine abnormality which is associated with a decreased chanceof pregnancy

  9. Inadequate visualization of 1 or both ovaries

  10. One or both ovaries not accessible for oocyte retrieval

  11. Has a history of recurrent pregnancy losses (i.e., >3 pregnancy losses)

  12. Has a history or current evidence of human immunodeficiency virus (HIV) Note:Results obtained within 1 year prior to signing the informed consent form areconsidered valid.

  13. Has tumors of the ovary, breast, uterus, pituitary, or hypothalamus

  14. Has a history of epilepsy, thrombophilia, diabetes, untreated or inadequatelytreated subclinical hypothyroidism, clinically significant cardiovascular,gastrointestinal, hepatic, renal, pulmonary, or auto-immune disease requiringtreatment within the last 3 years

  15. Is a current smoker who smokes ≥5 cigarettes per day

  16. Is assessed by the Investigator as unlikely or unable to adhere to dose and/or visitschedules

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Ubiquinol 100 MG Oral Capsule
Phase: 2
Study Start date:
January 23, 2025
Estimated Completion Date:
January 31, 2027

Study Description

As more women choose to delay child rearing, it has become increasingly important to understand why fertility declines with increasing maternal age. One of the factors suggested to play a role in reproductive aging is mitochondrial aging. Mitochondria are considered to be the batteries of the eggs and are responsible for generating energy necessary for egg and subsequent embryo development.

The egg maturation process involves a combination of many changes - all of which require energy that is provided by the mitochondria. Coenzyme Q10 (CoQ10) plays an important role as fuel in this process.

The investigators have shown that CoQ10 is needed for proper energy production by mitochondria and its addition to the diet could act as a potential treatment for egg aging.

It has been shown that in an aged mouse model, administration of CoQ10 (ubiquinone) results in improved mitochondrial energy production, more healthy embryos and more live-born pups. In clinical studies, the investigators also showed potential beneficial effects to increase the number of normal embryos from human eggs in older patients. So far, only one small study measured CoQ10 concentrations in the fluid that surrounds the eggs inside the ovaries (follicular fluid) and found significantly higher CoQ10 in the follicular fluid of normal mature eggs vs abnormal eggs. In addition, higher CoQ10 concentrations were also associated with better quality embryos. This study supports the hypothesis that CoQ10 supplementation may improve egg and embryo quality.

So far, all the research studies of CoQ10 in reproductive aging have administered a form of CoQ10 called ubiquinone. Another form of CoQ10 (ubiquinol), appears to be absorbed by the body better than ubiquinone and may have other beneficial effects in the ovary besides just increasing energy production.

Connect with a study center

  • Trio Fertility

    Toronto, Ontario M5G 2K4
    Canada

    Active - Recruiting

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